CN106068108A - 用于递送人工二尖瓣和锚固装置的装置、系统和方法 - Google Patents
用于递送人工二尖瓣和锚固装置的装置、系统和方法 Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0069—Three-dimensional shapes cylindrical
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
Abstract
提供了允许改善的植入程序的人工二尖瓣心脏瓣膜和用于与这种瓣膜一起使用的锚固件。在各种实施例中,螺旋锚固装置(5)被形成为包括一个或更多个回转部的旋绕的或卷绕的锚固件,所述回转部围绕中心轴线卷绕或弯曲。当螺旋锚固装置(5)离开递送导管时,被附接到瓣膜的框架(48)的弯曲臂(43)将螺旋锚固装置(5)引导到在瓣膜小叶下方并且在二尖瓣环附近的位置,并且可扩展人工二尖瓣被保持在锚固装置的线圈内。锚固装置和瓣膜能够一起被递送,从而简化瓣膜置换程序。
Description
技术领域
背景技术
已知二尖瓣的并发症导致致命的心脏衰竭,其中二尖瓣控制血液从人体心脏的左心房流入到左心室。在发达国家中,瓣膜性心脏疾病的最常见形式之一是二尖瓣渗漏,也被称为二尖瓣反流,其特征为血液从左心室通过二尖瓣异常渗漏并返流到左心房内。这种情况发生的最常见原因是由于当二尖瓣的小叶在多次梗塞、特发性心肌病和高血压性心肌病之后不再正确地接触或闭合时造成的缺血性心脏疾病,其中左心室增大,并且伴有小叶和腱索异常,诸如由变性疾病所导致的那些异常。
除了二尖瓣反流之外,风湿性疾病能够导致二尖瓣变窄或狭窄。虽然在发达国家中这种疾病事实上已被消除,但在生活质量不高的地方仍是常见的。
在过去的十年的过程中,很多公司已经成功地制备出导管或微创可植入的主动脉瓣,但二尖瓣的此类植入是更困难的。患者受益于通过采用小切口的微创手术程序或通过诸如从腹股沟的导管植入而植入装置。从患者的角度来看,导管程序是非常有吸引力的。需要二尖瓣置换的许多患者是老人,并且心脏直视程序是痛苦的、有风险的且需要一定的时间进行康复。有些患者因年事已高且虚弱甚至不建议进行这样的手术。
发明内容
之前的文件(例如,国际PCT公开号WO2013/114214,因此其公开内容以引用的方式被并入本文)已经提供了关于经由导管或微创程序将二尖瓣假体附接在患者中的锚固件的使用的公开内容。通常在这些公开内容中共同描述的大部分锚固件是螺旋锚固件,所述螺旋锚固件首先被放置在原生二尖瓣环附近,并且然后人工瓣膜被植入锚固件内部。在人工瓣膜被放置之后添加螺旋锚固件也将会是可能的。螺旋锚固件能够被放置以改善假体的稳定性,从而防止摇摆或甚至控制在瓣膜周围发生的渗漏。不论锚固件是在瓣膜植入之前还是之后被放置,对于介入人员来说这都会产生两步骤程序。介入人员必须首先放置锚固件,并且然后放置人工瓣膜,或反之亦然。
将会有益的是具有将锚固件递送与瓣膜递送进行组合以简化程序的装置和方法。单个手术程序还能够减少对患者的影响。
本发明的实施例包括用于递送人工二尖瓣和锚固装置(诸如螺旋锚固装置)的递送装置和系统及其方法。人工二尖瓣和螺旋锚固装置能够被容纳在单个程序中将人工二尖瓣和螺旋锚固装置两者递送到患者的二尖瓣位置的导管内。
根据本发明的实施例,二尖瓣假体包括可扩展瓣膜框架和多个臂,每个臂均在瓣膜框架的第一端处或附近被连接到瓣膜框架。来自多个臂之中的第一臂具有与其他臂中的每个臂的形状不同的形状。第一臂被配置为在瓣膜框架附近引导螺旋锚固装置。
根据另一实施例,二尖瓣假体包括可扩展瓣膜框架、第一臂和锚固装置,第一臂具有第一端和第二端,第一端被附接到瓣膜框架,第二端被配置为当瓣膜框架在扩展的构造中时相比于瓣膜框架从中心轴线的延伸,从瓣膜框架的中心轴线径向地延伸得更远,锚固装置包含限定内部空间的线圈(coil)。当瓣膜框架在扩展的构造中时,瓣膜框架被锚固装置保持在线圈的内部空间中。
根据另一实施例,用于将二尖瓣假体递送到心脏的原生二尖瓣的方法包括,将导管定位在原生二尖瓣处,将臂和瓣膜框架的第一端推进到导管之外到达心脏的左心室,将锚固装置推进到导管之外,在原生二尖瓣的小叶和腱索附近进入左心室,其中锚固装置在锚固装置的推进期间由臂的至少一部分引导,以及将瓣膜框架的其余部分推进到导管之外,其中瓣膜框架被扩展,并且被保持在由锚固装置的线圈限定的内部空间中。
附图说明
利用附图根据实施例的描述,进一步的特征和优点将会是显而易见的。在附图中:
图1A-1B示出了根据本发明的第一实施例的递送导管的末端的特写透视图,其中人工瓣膜和螺旋锚固装置正在从所述递送导管的末端被递送。
图2A-2F是根据第一实施例的图示采用递送系统将螺旋锚固装置和人工二尖瓣植入心脏的二尖瓣位置中的过程的部分横截面示意图。
图3A-3B示出了根据第二实施例的递送导管的末端的特写透视图,其中具有经更改的臂的人工二尖瓣正在从所述递送导管的末端被递送。
图4A-4B示出了根据进一步实施例的瓣膜递送导管和邻近的螺旋锚固件递送导管的末端的特写透视图,其中人工二尖瓣和螺旋锚固装置分别从所述瓣膜递送导管和邻近的螺旋锚固件递送导管的末端被递送。
图4C示出了在分别从邻近的螺旋锚固件递送导管和瓣膜递送导管递送之后图4A-4B的螺旋锚固装置和人工瓣膜的特写透视图。
具体实施方式
在本文中公开的是允许简化和改善的植入的人工二尖瓣心脏瓣膜和用于与这种瓣膜一起使用的锚固件。在各种实施例中,螺旋锚固装置被形成为包括一个或更多个回转部(turn)的旋绕的或卷绕的锚固件,所述回转部围绕中心轴线卷绕或弯曲。人工二尖瓣被扩展,并且被保持在线圈内。锚固件和瓣膜能够在简单的程序中被递送。通过将锚固件放置与瓣膜植入进行组合,患者受益于更快并且更简单的人工瓣膜植入过程。
图1A-1B示出了根据本发明的第一实施例的递送导管10的末端的特写透视图,其中人工瓣膜4和螺旋锚固装置5正从所述递送导管10的末端被递送。为了清楚,在这些图中省略了心脏的结构。
图1A示出了人工瓣膜4,其中一部分从递送导管10延伸,并且一部分仍然被保持在递送导管10中。人工瓣膜4包括瓣膜框架48,瓣膜框架48从瓣膜框架48的直径被减小的皱缩位置或构造可扩展到瓣膜框架48的直径被增加的扩展位置或构造。瓣膜框架48能够被皱缩以便于通过递送导管10的递送,并且能够在原生二尖瓣处的放置期间或之后被扩展,以便接合二尖瓣环或在二尖瓣位置处放置的锚固装置5,如将会在下面更详细地进行讨论。瓣膜框架48进一步容纳多个小叶41(例如,如在图2F中示出的),用于调节或控制通过人工瓣膜4的血流。
人工瓣膜进一步包括多个臂43,所述多个臂43被附接到瓣膜并且从瓣膜框架48延伸。臂43能够被附接到瓣膜框架48的远端,使得臂43在人工瓣膜4的递送期间在瓣膜框架48之前开始离开导管10。替代地,臂43能够向上朝向瓣膜框架48的中心、远离远端被附接得更高(例如,如在图2F中看见的)。臂43是弯曲的,其中第一部分远离瓣膜框架48的末端向远侧延伸,并且第二部分向上朝向瓣膜框架48弯曲回来并从瓣膜框架48径向向外地延伸。即使在瓣膜框架48已经被扩展之后,臂43的第二部分一般也将会比瓣膜框架48更进一步地径向向外延伸。臂43以此方式被成形,以便于定位在原生二尖瓣小叶附近。
臂43中的至少一个与其他臂43不同地布置(例如,具有不同的形状)。图1A示出了最左边图示的臂43的远端处的环圈42。环圈42通过使臂的末端进一步弯曲以限定圆形开口而被形成。由环圈42限定的开口的尺寸使得螺旋锚固装置5能够穿过环圈42并且被引导通过环圈42。环圈42也可以稍微更大,以便还保持和/或引导通过其部署螺旋锚固装置5的螺旋锚固件递送导管11。环圈42允许螺旋锚固件递送导管11旋转并且被调整到期望的递送位置内。
螺旋锚固件递送导管11被用来部署并且定位螺旋锚固装置5。螺旋锚固件递送导管11能够在通过导管10的人工瓣膜4的递送期间最初穿过人工瓣膜4的环圈42,或被保持在人工瓣膜4的环圈42中。以此方式,臂43的部署自然也将会弯曲,和/或要不然将螺旋锚固件递送导管11定位到用于递送螺旋锚固装置5的期望位置内或附近。在其他实施例中,在相应的部分已经从导管10被递送之后,螺旋锚固件递送导管能够替代地被引导到环圈42并且通过环圈42。在图1A和1B中示出的实施例,螺旋锚固件递送导管11被定位在导管10中的人工瓣膜4中,并且穿过导管10中的人工瓣膜4。然而,在其他实施例中,螺旋锚固件递送导管11能够替代地被定位在导管10中的人工瓣膜4旁边(即,平行于人工瓣膜4),或例如能够被完全定位在导管10的外面,如在图4A-4B中示出的并且如将会稍后关于图4A-4B讨论的。
在一些实施例中,螺旋锚固件递送导管11能够具有预成形形状,该预成形形状就便于一旦螺旋锚固件递送导管11从递送导管10被递送,就定位螺旋锚固件递送导管11。在一些实施例中,螺旋锚固件递送导管11能够通过各种手段中的一种手段可操纵。
图1A和1B示出了螺旋锚固装置5正从螺旋锚固件递送导管11被推出或要不然被递送的初始过程。如将会在下面更详细地讨论的,螺旋锚固装置5被形成为旋绕的或卷绕的锚固件,所述锚固件包括绕中心轴线卷绕或弯曲的一个或更多个回转部。螺旋锚固装置5限定大致圆形或圆柱形内部空间,人工瓣膜4的瓣膜框架48能够在该内部空间中扩展并且被保持在该内部空间中。螺旋锚固装置5能够被预成形为具有旋绕的或卷绕的形状,并且由以下材料制成或包括以下材料,当螺旋锚固装置5被保持在螺旋锚固件递送导管11中时,该材料允许螺旋锚固装置5变形(例如,变直),并且其中当锚固装置5从螺旋锚固件递送导管11被递送时,锚固装置5恢复回到其旋绕的形状。螺旋锚固装置5的曲率尺寸和/或半径和螺旋锚固递送导管11的定位使得当锚固装置5正在被部署时,锚固装置5能够完全围绕原生二尖瓣小叶和腱索(chordae tendineae)被引导。图1A示出了锚固装置5的部署的开始阶段,其中仅锚固装置5的远侧顶端从螺旋锚固递送导管11延伸,而图1B示出了正在绕人工瓣膜4的瓣膜框架48被部署几乎一整圈的锚固装置5。人工瓣膜4和锚固装置5两者关于心脏的各种特征的植入将会在下面关于图2A-2F更详细地讨论。
图2A-2F示出了根据第一实施例的用于将人工二尖瓣4和螺旋锚固装置5定位在患者的心脏2的原生二尖瓣3处的递送系统100和方法。
图2A示出了包括导管1的递送系统100,该导管1已经通过外周静脉(例如,下腔静脉21)被推进心脏2中、进入右心房22、跨过心房隔膜23到达左心房24并且通过原生二尖瓣3,使得导管1末端在左心室25中位于原生二尖瓣3附近。导管1能够通过经皮穿刺或通过患者的腹股沟处向下的小手术切口被引入患者的静脉系统,这是众所周知的。替代地,导管1能够在下腹部或腹膜后区域、或颈部中、或通过锁骨下或腋下静脉的肩部区域、或颈部中的颈静脉系统中的任何地方被引入。在进一步的实施例中,导管1能够通过上腔静脉26被引入,或能够通过左心房24的外壁直接进入心脏2。如在图2A中示出的,递送导管10从导管1延伸,并且被定位在左心室25中。
导管10容纳或保持能够被植入患者的原生二尖瓣3的区域中的人工二尖瓣4,如在图2E-2F中所示。人工瓣膜4如之前讨论的那样是可扩展的,并且能够自扩展。镍钛诺通常被用来制造该自扩展人工瓣膜4的瓣膜框架48,但是其他形状记忆材料也能够被使用。瓣膜框架如在图2F中示出的那样容纳人造小叶41,该人造小叶41通常由牛或猪心包膜制成。小叶41也能够是合成的,或从诸如人类尸体或通过生物组织工程的其他来源获得。一种具有有利性质的生物材料是从小肠黏膜获得的组织。
图2B示出了位于左心脏27内部的导管1的特写视图,其中递送导管10的顶端12刚好在二尖瓣3的原生小叶31下方。人工瓣膜4的一部分已经在左心室25内从递送导管10被递送(例如,被向外部署),使得环圈42从递送导管10的顶端12突出。
图2C示出了人工二尖瓣4从递送导管10的进一步递送。臂43从位于左心室25中的人工瓣膜4的瓣膜框架48的末端或在该末端附近延伸,并且环绕原生小叶31并用于倚着原生二尖瓣小叶31的边缘牢固地锚固人工瓣膜4。箭头图示了在臂43已经从递送导管10被向外部署之后臂43环绕原生二尖瓣小叶31的下边缘的方向。当人工瓣膜4被完全定位时,臂43将会帮助防止人工瓣膜4向上移位到左心房24内。
多个臂43用于提供人工二尖瓣4到原生二尖瓣3的附接的下表面。臂43能够在长度上以及在特征和结构方面改变。应理解,尽管为了图示的目的而在图2A-2F中仅示出了两个臂,多于或少于两个臂43能够与该实施例一起使用。
臂43中的一个在其最远端或远端处具有环圈42,以导向或控制容纳螺旋锚固装置5的螺旋锚固件递送导管11。在该实施例中,螺旋锚固件递送导管11已经被预先装载到环圈42内。包括环圈42的臂43能够具有比其他臂43更重的结构,并且不必类似于其他臂或不必类似于不包括环圈42的臂43。
臂43具有形状记忆性质或要不然是弹性的,使得当它们从递送导管10被向外部署时,它们能够回复回到其弯曲形状并且环绕原生二尖瓣小叶31。
具有环圈42的臂43环绕原生二尖瓣小叶31,并且附接的螺旋锚固件递送导管11通过环圈42被运送,使得腱索32和患者的二尖瓣小叶31位于螺旋锚固装置5的暴露端内部(即,在螺旋锚固装置5的暴露端的弯曲部的凹侧)。当螺旋锚固装置5从该位置被推进时,它将会包围腱索32,使得原生二尖瓣小叶31和腱索32将会被捕获在由螺旋锚固装置5产生的圆内部,如稍后将会看见的。
臂43的末端处的环圈42使螺旋锚固件递送导管11在小叶31附近并且在腱索32上方回转到原生二尖瓣环34下方的优选位置。该特定臂43能够具有将人工瓣膜4附接到小叶边缘并且引导螺旋锚固装置5的递送的双重功能。环圈42能够充分大,以当该系统被部署时允许螺旋锚固件递送导管11转动或旋转。
螺旋锚固装置5优选在靠近、平行于原生二尖瓣3的下侧的平面中被递送。螺旋锚固件递送导管11也通过环圈42被瞄准或被导向到该平面。在一个实施例中,环圈42能够包括迫使螺旋锚固件递送导管11进入有利平面和取向的短管。或者,螺旋锚固件递送导管11能够是可操纵的。许多可操纵导管在本技术领域中是已知并且可获得的。
在进一步的实施例中,除环圈42之外的装置也能够导向螺旋锚固装置5的递送。例如,构成人工二尖瓣4的一部分的支架框架的单元也能够执行与在这里示出的环圈42相同的功能。钩或管也能够被使用。能够在原生小叶31附近导向螺旋锚固装置5的任何结构都能够被添加到人工瓣膜4。结构能够被永久地制造在人工瓣膜4中,或能够是暂时的。例如,缝合线的环圈能够被用来产生环圈42。缝合线然后被撤回。在其他实施例中,具有臂或翼的更早的二尖瓣假体能够用当前人工瓣膜4的环圈42来更改或改进,以便利于螺旋锚固装置5的递送。
图2C-2F中的臂43能够是相当纤细的。实际上,臂43能够由被熔合在臂43的末端45处的多对或三重丝构成。到臂43的这些狭窄终端45便于臂43在二尖瓣小叶31的自由边33的边缘处在腱索32之间经过,以允许臂43环绕小叶31。腱索32在原生二尖瓣3的一些区域附近被紧密地包裹,并且纤细臂43将会更好地便于臂43在腱索32之间的经过。一旦臂43的纤细部分经过,臂43的更厚部分就能够通过使腱索32分散开而在它们之间移动。因此,在一些实施例中,臂43在顶端45处是纤细的(或由单个丝或丝的熔合构成),并且越靠近人工瓣膜4的主体越坚固(为了更有力的附接)。进一步的,臂43也能够比在图2C-2F中图示的更短或更长。
螺旋锚固装置5的部署能够在二尖瓣环34附近的任何地方开始。例如,螺旋锚固装置5的部署能够在小叶31的中部中或附近开始。这对于操作者将会是有利的,例如,操作者将不必精确地定位原生二尖瓣的连合处以开始锚固装置递送程序,由此简化该程序。
图2D示出了正在二尖瓣位置处的原生二尖瓣小叶31下方被递送的螺旋锚固装置5的特写示意图。箭头图示了螺旋锚固装置5在原生二尖瓣3下方从递送导管11被递送的方向。取决于被使用的特定螺旋锚固装置5,任何数量的回转部都能够被递送。螺旋锚固装置5的内直径能够优选稍微小于完全扩展的二尖瓣人工瓣膜4的外直径,以便促进螺旋锚固装置5与人工瓣膜4之间的接合。
部分递送的人工瓣膜4能够用于使螺旋锚固装置5的递送居中。还能够提供用于螺旋锚固装置5的递送的稳定平台。
在图2E中图示的实施例中,螺旋锚固装置5的三个回转部已经被放置在原生二尖瓣3下方。原生二尖瓣小叶31被定位在螺旋锚固装置5与人工二尖瓣4之间,该人工二尖瓣4在图2E中被示为将要扩展。一旦人工瓣膜4被扩展,螺旋锚固装置5帮助牢固地定位人工瓣膜4,并且通过将原生小叶31密封到人工瓣膜4或倚着人工瓣膜4密封原生小叶31而防止人工瓣膜4周围的渗漏。螺旋锚固装置5与人工瓣膜4之间的相对力帮助定位并且稳定人工瓣膜4。
在图2E中,为了简单,已经省略了递送导管10。实际上,当递送导管10已经被移除时,人工瓣膜4将会在图2E中弹性打开(箭头指示人工瓣膜4将会正常弹性打开的方向)。然而,在图2E中,人工瓣膜4仍然在闭合位置中,以便允许在原生二尖瓣3下方的螺旋锚固装置5的回转部的清楚可视化。在该实施例中,人工瓣膜4进一步包括从瓣膜框架48的第二端或在其附近延伸或突出的可扩展心房部分46,所述瓣膜框架48的第二端与臂43从其延伸的末端相对。心房部分46被配置为倚着左心房24的壁被保持或抵靠在左心房24的壁上,以帮助进一步将人工瓣膜4稳定在二尖瓣位置处。人工瓣膜4的心房部分46能够扩展到大于二尖瓣环34的尺寸,例如,以限制人工瓣膜4到左心室25内的移动。
在图2E的实施例中,存在螺旋锚固装置5的三个回转部,但是任何数量的回转部都能够被使用。回转部向上倚着二尖瓣环34和小叶31的下侧设置,以便当左心室25收缩时提供可靠支撑,以将螺旋锚固装置5固定在适当位置的,并且防止人工瓣膜4到左心房24内的移动。由于臂43环绕螺旋锚固装置5,因此整个结构被稳定在适当位置。
能够可选地与人工瓣膜同时被递送的螺旋锚固装置的使用为介入人员提供相当大量的选择。例如,人工瓣膜4的一些实施例能够被重新插入鞘,即被重新插入递送导管10,从而允许人工瓣膜4被部分地推进并且针对其在程序期间的装配进行测试。如果操作者不喜欢在人工瓣膜4的最终释放之前进行定位,那么人工瓣膜4能够被拉回到递送导管10内。
在使用的一些方法中,能够在螺旋锚固装置5未在适当位置的情况下首先定位人工瓣膜4。如果人工瓣膜4的锚固看起来是坚固和稳定的并且不存在移动或渗漏的情况,那么能够在没有螺旋锚固装置5的情况下释放人工瓣膜4。另一方面,如果在没有螺旋锚固装置5的情况下例如操作者不满意人工瓣膜4在二尖瓣位置中的位置或稳定性,那么人工瓣膜4能够被拉回到递送导管10内。然后,螺旋锚固装置5能够被首先放置,并且人工瓣膜4能够在其中被定位并且被扩展。这将会让用户基于每个个体程序决定对螺旋锚固装置5的额外锚固的临床需要。
在图2F中,在二尖瓣位置中示出了完全植入的人工瓣膜4。臂43已经环绕原生二尖瓣小叶31,以防止人工瓣膜4向上移动到左心房24内。原生二尖瓣小叶31被紧紧地压缩在臂43下方,并且可靠的机械结构已经被产生,以防止人工瓣膜4移位。
螺旋锚固装置5的回转部还倚着人工瓣膜4的主体压缩,以定位、取向并且防止人工瓣膜4的移动。螺旋锚固装置5提供了人工瓣膜4的主体到原生二尖瓣小叶31的摩擦附接,并且用于锚固环绕螺旋锚固装置5的臂43。
人工二尖瓣4的上心房部分46被示为具有宽区域,所述宽区域位于左心房24内部以促进到左心房24的壁的附接或倚着左心房24的壁的抵靠。然而,趋向于将人工二尖瓣4从左心房24迫使到左心室25内的力或压力低,并且因此心房部分46可以不是必需的,并且能够根据一些实施例在临床假体中被省掉或被减小。
螺旋锚固装置5的回转部帮助克服患者的小叶31的长度的差异、腱索32的长度的差异、以及左心室25中的腱索32的附接点的差异。当具有环绕小叶31的臂43的人工二尖瓣被使用而无在小叶31下方绕行的任何螺旋状物或锚固件时,人工二尖瓣的固定的深度和坚固性能够在植入的人工二尖瓣的周边附近改变。例如,如果被附接到后小叶31的中间部分的腱索32是非常细长的或破裂的(常见情况),那么臂43不能在该位置处环绕和接合小叶31。或者,臂43中的一个与小叶31之间能够存在非常有限的接合,从而引起臂43移动到更靠近瓣膜环34的更高平面或在更靠近瓣膜环34的更高平面处达到静止。如果这些中的任一个发生,那么发生这种情况的人工瓣膜的部分将会位于更高或更靠近原生二尖瓣3,这会在人工瓣膜中产生歪斜,因此人工瓣膜应与瓣膜的入流平面成一角度设置。当心脏跳动时,人工瓣膜上存在大负荷,并且它可能开始振动并且漂移。心脏每天跳动大约100,000次,并且在几天或几周或几月之后,人工瓣膜可能漂移、移动并且移位。而且,如果小叶31或腱索32是非常细长的,那么与臂不会存在接触,并且也不会形成植入物周围的有效密封。由于缺少人工瓣膜与原生二尖瓣小叶31的接合,这能够导致大的瓣膜旁的渗漏。小叶31下方的螺旋锚固装置5能够倚着人工瓣膜压缩小叶组织,并且防止这种问题。螺旋锚固装置5能够位于一个平面中,并且防止与患者解剖结构的差异有关的问题。
在临床实践中,在小叶31的尺寸、小叶31的特征、腱索长度、和腱索32的附接以及二尖瓣环34的直径方面实际上存在无限的差异。螺旋锚固装置5在小叶31下方的使用抵消了这些差异中许多,因为臂43的固定点能够被带到螺旋锚固装置5的最下回转部。该位置能够通过选择螺旋锚固装置5的回转部的数量和螺旋锚固装置5的厚度以在人工瓣膜4的最小部分处匹配臂43的转弯点而被事先确定。
因此,螺旋锚固装置5能够为人工二尖瓣4的臂43的锚固产生共同的且预定的平面。在之前描述的情况下,其中腱索32中的一些被伸展并且其中要不然在没有螺旋锚固装置5的情况下人工瓣膜4之间的接触可以是宽松的或更不牢固的,人工二尖瓣4在该区域中的附接能够替代地是到螺旋锚固装置5。这将会为人工二尖瓣4的最下点产生共同的平面。
因此,螺旋锚固装置5的更多回转部能够被添加,以确保人工瓣膜4的臂43遍及其周边始终在共同的最下平面处。在一些实施例中,螺旋锚固装置5能够被制作得更厚。在一些实施例中,波形或波动能够被添加到螺旋锚固装置5的回转部,以扩展螺旋锚固装置5的高度。
螺旋锚固装置5因此通过为人工瓣膜4的臂43提供用于环绕的锚固点而改善人工瓣膜4的稳定性,并且同时螺旋锚固装置5能够沿着其长度捕获人工瓣膜4的圆筒的周边。这些特征的组合为人工瓣膜4提供极大稳定性。它还倚着人工瓣膜4密封原生二尖瓣3,以防止瓣膜旁的渗漏。
此外,患者的原生二尖瓣(即,小叶31、环34和腱索32)出现所有变化和组合。对于制造商来说更不实际的是制作不同长度和深度的锚固臂31,而对于操作者来说更不实际的是将这些产品完美地递送到患者内部的位置。能够更实际的是,通过将螺旋锚固装置5放置在人工瓣膜4下方并且利用该螺旋锚固装置5产生用于臂43倚着锚固的最下平面来针对这些差异进行调整。
图3A-3B示出了根据第二实施例的递送导管10的末端,人工瓣膜4’正在从递送导管10的末端被递送。为了清楚,在这些图中已经省略了心脏2的结构。
在上述的实施例中,在原生二尖瓣小叶31下方递送螺旋锚固装置5的螺旋锚固件递送导管11与人工装置4分开。在图3A-3B中图示的实施例中,螺旋锚固件递送导管已经作为更改的臂43’被并入到人工瓣膜4’内。人工瓣膜4’包括更改的臂43’,更改的臂43’环绕二尖瓣小叶31中的一个,类似于其他臂43。在这里,更改的臂43’是中空管,中空管能够与螺旋锚固装置5一起被装载,并且中空管被设计尺寸成使得螺旋锚固装置能够被推进通过其中。更改的臂43’包括弯曲47和在相对于臂43’的其余部分成一角度的远端处的部分,使得臂43’的远侧部分围绕人工瓣膜4’周向地延伸。中空管的开口因此围绕人工瓣膜4’周向地指向,以帮助围绕原生二尖瓣小叶31和腱索32导向螺旋锚固装置5。然而,人工瓣膜4’的更改的臂43’上的任何结构或人工瓣膜4’的能够引导螺旋锚固装置5的任何部分能够足以将螺旋锚固装置5导向到正确位置。当更改的臂43’环绕二尖瓣小叶31中的一个时,螺旋锚固装置5被运送到正确位置并且到正确平面以便递送。更改的臂43’能够被预成形,并且由诸如镍钛诺的形状记忆材料制作。
图3B示出了螺旋锚固装置5的从管状臂43’延伸的几乎一整个回转部。如在上面描述的,螺旋锚固装置5能够在原生二尖瓣小叶31下方或附近完成多个回转部。如在该实施例中示出的,人工二尖瓣能够被更改为运送螺旋锚固装置5而不需要单独的螺旋锚固件递送导管被定位在原生二尖瓣小叶31下方或附近。
图4A-4B示出了递送导管10的末端和邻近的螺旋锚固件递送导管11”的特写透视图。
在图1A-1B中示出的实施例中,螺旋锚固件递送导管11被定位在导管10中的人工二尖瓣4内部。然而,在该实施例中,螺旋锚固件递送导管11”和人工瓣膜4”被并排地递送。如在图4A-4B中示出的,人工瓣膜4能够与图1A-1B的实施例中的人工瓣膜4类似地被构建。螺旋锚固件递送导管11”替代地被定位在递送人工二尖瓣4”的递送导管10外部。螺旋锚固件递送导管11”穿过人工二尖瓣4”中的臂43中一个中的环圈42。邻近螺旋锚固装置5的箭头展示了螺旋锚固装置5正在从螺旋递送导管11”的末端被递送的方向。
图4B示出了从螺旋锚固件递送导管11”进一步延伸的螺旋锚固装置5。螺旋锚固件递送导管11”的末端仍然在臂43中的一个的末端处的环圈42中,并且螺旋锚固装置5的几乎一整个回转部已经被递送。
图4C示出了在分别从螺旋锚固件递送导管11”和递送导管10递送之后图4A-4B的螺旋锚固装置5和人工瓣膜4”的特写透视图。
在图4C中,螺旋锚固装置5的大约三个回转部已经在原生二尖瓣3的示意地图示的平面35下方被递送。然而,能够提供螺旋锚固装置5的任何数的回转部,以便为人工瓣膜4”提供支撑。为了简便起见,螺旋锚固件递送导管11”已经在图4C中被移除。递送人工瓣膜4”的递送导管10也已经被移除。如在上面关于图2E讨论的,当递送导管10被移除时,人工瓣膜4”的主体一般将会弹性打开。但是为了图示的目的,人工瓣膜4”在图4C中示出在其闭合位置中,以使螺旋锚固装置5和人工瓣膜4”的可视化更清楚。
各种其他更改或替代性构造能够被制作为根据本发明的上述实施例的人工瓣膜、螺旋锚固件和/或递送系统。例如,可以替代地布置瓣膜假体的任何变化,其中螺旋锚固件的受控部署能够通过与螺旋锚固件本身或与用于递送螺旋锚固件的导管互动的假体的一部分来促进。互动特征可以体现为上述实施例中的一些中描述的瓣膜假体的臂,或可以是被布置在瓣膜假体的另一部分上的特征。关于螺旋锚固件,线圈的数量能够基于例如原生二尖瓣的性质和/或瓣膜假体的期望定位被进一步改变。各种其他线圈形状、长度和布置以及更改也能够基于宽范围的考虑进行。
为此说明书的目的,在此描述本公开的实施例的某些方面、优点和新颖特征。所公开的方法、装置和系统不应被解释为限制性的。反而,本公开涉及所公开的各种实施例的所有新颖的且非显而易见的特征和方面,其可以是单独的以及彼此的各种组合和子组合。该方法、装置和系统不限于其中任何特定方面或特征或组合,本公开的实施例也不需要任一或更多的特定优点的存在或问题被解决。
尽管为方便表达,以特定的、按次序的顺序描述所公开的实施例的一些的操作,但是应理解这种描述方式包含重新排列,除非在下面阐述的特定的语句要求特定的顺序。例如,按次序描述的操作可以在某些案例中被重新排列或并行执行。而且,为简单起见,附图可以不示出所公开的方法可以与其他方法结合使用的各种方法。此外,描述有时使用像“提供”或“实现”一样的术语来描述所公开的方法。这些术语是被执行的实际操作的高水平提取。对应于这些术语的实际操作可以依据具体实施方式而改变,并且可由本领域技术人员容易分辨。
鉴于可以应用公开内容的原理的许多可能的实施例,应当认识到,图示的实施例仅是优选示例,并不应当被认为是对公开内容的范围进行限制。确切地说,公开内容的范围由以下权利要求进行限定。
Claims (20)
1.一种被配置为植入在心脏的原生二尖瓣处的二尖瓣假体,所述二尖瓣假体包括:
可扩展瓣膜框架;以及
多个臂,每个臂在所述瓣膜框架的第一端处或附近被连接到所述瓣膜框架;
其中来自所述多个臂之中的第一臂具有与其他臂中的每个臂的形状不同的形状,所述第一臂被配置为在所述瓣膜框架附近引导锚固装置。
2.根据权利要求1所述的二尖瓣假体,其中环圈被形成在所述第一臂的末端处,并且被设计尺寸使得所述锚固装置能够穿过其中。
3.根据权利要求2所述的二尖瓣假体,其中所述第一臂的所述末端被弯曲以形成所述环圈。
4.根据权利要求1至3中的任一项所述的二尖瓣假体,其中所述第一臂包含被设计尺寸以允许所述锚固装置穿过其中的中空管。
5.根据权利要求4所述的二尖瓣假体,其中所述中空管从所述瓣膜框架处的连接延伸到所述第一臂的相对端。
6.根据权利要求4或5所述的二尖瓣假体,其中所述第一臂的末端是弯曲的,使得所述中空管的一部分围绕所述瓣膜框架周向地延伸。
7.根据权利要求1至6中的任一项所述的二尖瓣假体,其中所述第一臂具有比所述其他臂中的每一个更重的结构。
8.根据权利要求1至7中的任一项所述的二尖瓣假体,其中当所述瓣膜框架在扩展的构造中时,所述臂中的至少一个是弯曲的,并且具有在所述瓣膜框架外部被轴向地对齐并且被径向地定位的区段。
9.根据权利要求1至8中的任一项所述的二尖瓣假体,其进一步包含锚固装置,所述锚固装置包含限定容纳所述瓣膜框架的内部空间的线圈。
10.一种被配置为植入在心脏的原生二尖瓣处的二尖瓣假体,所述二尖瓣假体包括:
可扩展瓣膜框架;
第一臂,其具有第一端和第二端,所述第一端被附接到所述瓣膜框架,所述第二端被配置为当所述瓣膜框架在扩展的构造中时相比于所述瓣膜框架从所述中心轴线的延伸,从所述瓣膜框架的中心轴线径向地延伸得更远;以及
锚固装置,其包含限定内部空间的线圈;
其中当所述瓣膜框架处于所述扩展的构造时,所述瓣膜框架被所述锚固装置保持在所述线圈的所述内部空间中。
11.根据权利要求10所述的二尖瓣假体,其中所述第一臂被配置为在所述瓣膜框架附近引导所述锚固装置。
12.根据权利要求11所述的二尖瓣假体,其中所述第一臂包含环圈,所述锚固装置被配置为穿过所述环圈。
13.根据权利要求11或12所述的二尖瓣假体,其中所述第一臂包含中空管,所述中空管被配置为容纳所述锚固装置以允许所述锚固装置穿过其中。
14.根据权利要求10至13中的任一项所述的二尖瓣假体,其进一步包含第二臂,所述第二臂被连接到所述瓣膜框架并且具有与所述第一臂的形状不同的形状。
15.一种用于将二尖瓣假体递送到心脏的原生二尖瓣的方法,所述二尖瓣假体包含瓣膜框架、臂和锚固装置,所述瓣膜框架被配置为从第一皱缩的构造扩展到第二扩展的构造,所述臂被连接到所述瓣膜框架,锚固装置包含线圈,所述方法包含:
将导管定位在所述原生二尖瓣处;
将所述臂和所述瓣膜框架的第一端推进到所述导管之外,到达所述心脏的左心室;
将所述锚固装置推进到所述导管之外,在所述原生二尖瓣的小叶和腱索附近进入所述左心室,其中所述锚固装置在所述锚固装置的推进期间由所述臂的至少一部分引导;以及
将所述瓣膜框架的其余部分推进到所述导管之外,其中所述瓣膜框架被扩展,并且被保持在由所述锚固装置的所述线圈限定的内部空间中。
16.根据权利要求15所述的方法,其中所述锚固装置在所述锚固装置的推进期间被引导通过所述臂的至少一部分。
17.根据权利要求15或16所述的方法,其中所述二尖瓣假体包含在所述第一端处或附近被连接到所述瓣膜框架的多个臂。
18.根据权利要求17所述的方法,其中所述多个臂被配置为围绕所述原生二尖瓣的所述小叶延伸。
19.根据权利要求18所述的方法,其中所述锚固装置被配置为在相对于所述瓣膜框架的中心轴线的径向方向上被定位在所述臂与所述瓣膜框架之间。
20.根据权利要求17至19中的任一项所述的方法,其中所述锚固装置形成用于支撑所述多个臂的共同平面。
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2015
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- 2015-02-20 MX MX2016010303A patent/MX2016010303A/es active IP Right Grant
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- 2015-02-20 EP EP23181653.9A patent/EP4248914A2/en active Pending
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- 2015-02-20 CN CN201910089176.1A patent/CN109674560B/zh active Active
- 2015-02-20 EP EP20196185.1A patent/EP3782585B1/en active Active
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- 2015-02-20 CN CN201580009732.XA patent/CN106068108B/zh active Active
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2018
- 2018-08-07 US US16/057,192 patent/US10898320B2/en active Active
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2021
- 2021-01-22 US US17/156,265 patent/US20210137678A1/en active Pending
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Publication number | Priority date | Publication date | Assignee | Title |
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CN110225728A (zh) * | 2017-01-24 | 2019-09-10 | 4C医学技术有限公司 | 用于假体心脏瓣膜的两步式输送和植入的系统、方法和装置 |
CN110225728B (zh) * | 2017-01-24 | 2023-04-18 | 4C医学技术有限公司 | 自扩张假体二尖瓣膜装置 |
CN110179566A (zh) * | 2019-04-11 | 2019-08-30 | 宁波健世生物科技有限公司 | 一种带有定位功能的假体输送系统 |
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CN109674560B (zh) | 2022-04-01 |
US10898320B2 (en) | 2021-01-26 |
EP3107498A2 (en) | 2016-12-28 |
SG11201606230YA (en) | 2016-08-30 |
US20150238313A1 (en) | 2015-08-27 |
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US20180344459A1 (en) | 2018-12-06 |
MX2016010303A (es) | 2017-04-27 |
WO2015125024A2 (en) | 2015-08-27 |
US20210137678A1 (en) | 2021-05-13 |
CN109674560A (zh) | 2019-04-26 |
WO2015125024A3 (en) | 2015-11-26 |
CA3189691A1 (en) | 2015-08-27 |
CA2937849C (en) | 2023-04-11 |
CA2937849A1 (en) | 2015-08-27 |
EP4248914A2 (en) | 2023-09-27 |
EP3107498B1 (en) | 2020-09-30 |
CR20160366A (es) | 2016-11-15 |
JP2017506119A (ja) | 2017-03-02 |
EP3782585B1 (en) | 2023-06-28 |
US10052199B2 (en) | 2018-08-21 |
CN106068108B (zh) | 2019-03-01 |
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